Kappas A, Drummond G S, Henschke C, Valaes T
Rockefeller University Hospital, New York, NY, USA.
Pediatrics. 1995 Apr;95(4):468-74.
Sn-mesoporphyrin (SnMP) is a potent inhibitor of bilirubin production. In our previous studies a single dose (6 mumol/kg birth weight) significantly moderated hyperbilirubinemia and reduced phototherapy (PT) time by > 75% when administered within 24 hours of birth to preterm infants.
To directly compare the efficacy of SnMP and PT for controlling hyperbilirubinemia in term and near-term infants.
Two randomized, sequentially analyzed trials (Study I: male term infants; Study II: infants of both sexes and gestational age [GA] 245-265 days) were conducted. SnMP (6 mumol/kg birth weight) or PT (Phillips F20T12/BB lamps) was administered to paired infants according to strict criteria of plasma bilirubin levels and age. Time of enrollment and closure of cases and crossover, if necessary, of SnMP infants to PT or all infants to exchange transfusion were precisely defined in each pair. SnMP or PT was considered superior if the time between enrollment and closure of the case was reduced by > 24 hours over the alternative treatment or if crossover had occurred.
None of the 44 SnMP-treated infants required supplemental PT. Of the 22 pairs of term infants enrolled in Study I, SnMP proved superior to PT in 20 and equal in two. Of the 20 pairs of near-term infants enrolled in Study II, SnMP was superior in 12 and PT in two; six were tied. Two SnMP-treated infants were unpaired. The PT-treated infants in Study I required an average of 33 hours of treatment; those in Study II, 48 hours. None of the enrolled infants required exchange transfusion or interruption of breast-feeding. In both studies, times between case enrollment and closure were reduced by > 30 hours in SnMP compared with PT infants; requirements for additional days of medical observation and bilirubin measurements were also significantly less in SnMP infants.
A single dose of SnMP entirely supplanted the need for PT in jaundiced term and near-term newborns and significantly reduced medical resource use to monitor hyperbilirubinemia.
锡-中卟啉（SnMP）是胆红素生成的有效抑制剂。在我们之前的研究中，对早产儿在出生后24小时内给予单剂量（6微摩尔/千克出生体重）的SnMP，可显著减轻高胆红素血症，并使光疗（PT）时间减少超过75%。
直接比较SnMP和PT控制足月儿和近足月儿高胆红素血症的疗效。
进行了两项随机、序贯分析试验（研究I：男性足月儿；研究II：男女均有且胎龄[GA]为245 - 265天的婴儿）。根据血浆胆红素水平和年龄的严格标准，对配对的婴儿给予SnMP（6微摩尔/千克出生体重）或PT（飞利浦F20T12/BB灯）。在每一对中精确界定病例入组和结束的时间以及交叉情况（如有必要，SnMP治疗的婴儿转为PT治疗或所有婴儿进行换血治疗）。如果病例入组和结束之间的时间比替代治疗减少超过24小时，或者发生了交叉情况，则认为SnMP或PT更优。
44例接受SnMP治疗的婴儿均无需补充PT。在研究I中入组的22对足月儿中，SnMP在20对中被证明优于PT，2对相当。在研究II中入组的20对近足月儿中，SnMP在12对中更优，PT在2对中更优；6对持平。2例接受SnMP治疗的婴儿未配对。研究I中接受PT治疗的婴儿平均治疗33小时；研究II中为48小时。所有入组婴儿均无需换血治疗或中断母乳喂养。在两项研究中，与接受PT治疗的婴儿相比，接受SnMP治疗的婴儿病例入组和结束之间的时间减少超过30小时；SnMP治疗的婴儿额外进行医学观察和胆红素测量的天数需求也显著更少。
单剂量的SnMP完全取代了黄疸足月儿和近足月儿对PT的需求，并显著减少了监测高胆红素血症的医疗资源使用。
